Social & Scientific Systems (S-3)

Clinical Monitor/Study Manager I

Location US-NC-Durham
Job ID
Data Management/Data Analysis
Regular Full-Time


Social & Scientific Systems (SSS) works to improve public health worldwide by providing technical, research, and program management services to government, nonprofit, and commercial clients. The SSS team offers a synergy of expertise in clinical research services, epidemiology and public health studies, health data management and analysis, and program evaluation and policy analysis. Please join our dedicated staff of employee-owners in an environment that values diversity and supports health, well-being, and professional growth.


SSS is seeking a Clinical Research Monitor / Study Manager to support clinical research and epidemiologic studies conducted by investigators at the National Institute of Environmental Health Sciences. A significant portion of the position will be to serve as a monitor of clinical studies, most of which are observational, conducted by investigators in the Clinical Research Branch (CRB) of the National Institute of Environmental Health Sciences (NIEHS). You will be responsible for performing and coordinating monitoring strategies and assuring compliance with GCP, ICH, and SOPs set forth by Social and Scientific Systems (SSS) and its clients.   In this position, you will also be responsible for the development and implementation of other research projects.  Study management responsibilities include development of timelines, staffing plans, budgets and subcontracts, protocol and study materials development, Institutional Review Board and other regulatory submissions, development and implementation of quality assurance plans and field site monitoring, and overall study communications.


The ideal candidate will have experience as a clinical monitor as well as some experience in the development and coordination of epidemiological or clinical research studies, be able to manage multiple projects simultaneously, be flexible, and enjoy working with a multidisciplinary team. Excellent oral and written communication skills are essential. The position is for full time and based in our Durham, NC office, but will require travel to clinical sites.



As monitor:

  • Prepares site-monitoring plans, schedules monitoring visits, conducts pre-visit tasks and conducts monitoring visits at designated clinical study sites according to SSS policies and procedures.
  • Completes comprehensive monitoring reports, quarterly reports and related correspondence in a timely manner following each monitoring visit, with no errors/edits needed.
  • Updates the Clinical Trial Management System (CTMS) in a timely manner to track required monitoring visits.
  • Keeps abreast of ICH/GCP guidelines, SOPs related to clinical monitoring and current clinical developments in assigned therapeutic areas, independently

As study manager:

  • Works with clients, develops technical approach, writes IRB and data collection protocols, designs related materials for projects, and prepares timelines.
  • Conducts staff trainings, and assigns and directs activities of research assistants, research associates, and other staff assigned to the project.
  • Collaborates with laboratory, data, field staff, and Telephone Research Center managers to estimate task specific resource requirements, and prepare preliminary budgets.
  • Collaborates with data managers on data monitoring, cleaning, and documentation activities.
  • Develops and maintains procedure manuals.
  • Provides project management support for specimen shipping, processing, and storage activities.
  • Leads the development of study quality assurance plans.
  • Works with programming staff to design study management systems for projects and devises electronic data collection approaches, consulting appropriately with clients to clarify requirements.
  • Works with the program manager to specify contract deliverables and plan timelines and project activities ensuring adherence to all contract requirements and delivery schedules.

General tasks:

  • Maintains a professional working relationship with all clients, investigators and clinical study sites. Professionally represents SSS to all parties.
  • Meets regularly with program manager to track estimates of cost and time for each project to ensure all work is performed within time and budget constraints.
  • Writes monthly project reports, ensuring that all staff reporting on the project provide accurate and complete descriptions of effort expended.
  • Performs additional duties as required.


  • MPH or equivalent and at least one year of experience managing small projects or major tasks
  • BS/BA degree in the life sciences or public health-related field or RN/BSN and 4 years project management experience


  •  Experience in clinical and/or epidemiological study monitoring; experience with risk-based approach a plus.
  • Experience in pharmaceutical, epidemiological, government-sponsored and/or investigator-initiated clinical research.
  • Excellent oral and written communication skills and strong organizational abilities.
  • Working knowledge of research principles and practices and regulatory requirements.
  • Prior public health project management experience.
  • Demonstrated ability to work independently and on a team.
  • Proficient with MS Office (Word, Excel, PowerPoint, and Outlook).
  • Effective time management strategies and practices.
  • Ability to balance the “big picture” with attention to detail.
  • Effective interpersonal skills including the ability to provide balanced feedback, motivate and train others.
  • Ability to proactively identify, prevent or resolve issues.
  • Ability to quickly come up to speed and self-start in a multitude of project environments and study staff.
  • Full driving license
  • Travel: up to 15%

SSS is committed to fostering a diverse workforce and is proud to be an Affirmative Action/Equal Opportunity Employer of Minorities/Women/Protected Veterans/Individuals with Disabilities. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, sex, age, national origin, veteran status, disability, or any other classification protected by law.


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